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POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA

Medicines Control Council (MCC), Department of Health Republic of South Africa, (2017)


This document has been prepared to serve as a guideline to those reporting adverse drug reactions.
http://www.mccza.com/documents/d449f6f32.33_ADR_re...


South Africa: GUIDELINES FOR THE REGISTRATION OF MEDICINES

Medicines Control Council (MCC), Department of Health Republic of South Africa, (2012)


This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
http://www.mccza.com/documents/1d9c57df2.01_Genera...


REPORTING ADVERSE DRUG REACTIONS IN SOUTH AFRICA

Medicines Control Council (MCC), Department of Health Republic of South Africa, (2012)


IMPORTANT NOTE: This guideline applies only to the reporting of SAEs during clinical trials. An update of the guideline for this purpose is being developed. The reporting of post-marketing ADRs is described in guideline 2.33 REPORTING OF POST-MARKETING ADVERSE DRUG REACTIONS TO HUMAN MEDICINAL PRODUCTS IN SOUTH AFRICA
http://www.mccza.com/documents/ae9635a42.11_ADR_re...


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